Advaxis Inc. submitted a Special Protocol Assessment request to the FDA to initiate detailed design discussions for a phase III clinical study of ADXS-HPV for the treatment of high-risk, locally advanced cervical cancer.
FDA approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to aid in the identification of patients for Pfizer's targeted therapy, Xalkori (crizotinib).
The European Commission has granted marketing authorization for Gardasil 9.
Lenvima (lenvatinib) launched in the U.K. as a treatment option for adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Janssen Research & Development initiated the rolling submission of its Biologic License Application for daratumumab to FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a PI and an IMiD.
Lenvima (lenvatinib) launched in the U.K. as a treatment option for adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
MD Anderson Cancer Center and Nektar Therapeutics announced a research collaboration that includes a phase I/II clinical study to evaluate NKTR-214, a CD122-biased cytokine designed to preferentially stimulate production of CD8-positive T cells.
FDA granted an orphan drug designation for APTO-253 for the treatment of acute myeloid leukemia.
Merck Canada Inc. announced that Keytruda (pembrolizumab) was authorized for sale with conditions by Health Canada.
FDA granted an Orphan Drug Designation to Reolysin for the treatment of malignant glioma.
